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Targeted Review of EU Pharmaceutical Legislation – The Community Code on Medicinal Products Needs to Remain a Directive


Christine Mellein, Jürgen Schwarze


The Covid-19 pandemic has highlighted the need for timely access to medicinal products. With its Pharmaceutical Strategy, the European Commission intends to make the EU pharmaceutical system more future proof and crisis resistant. The identified measures shall be accompanied by a targeted review of the basic pharmaceutical legislation - consisting of Regulation (EC) No 726/2004 and Directive 2001/83/EC. The final form of the legislative instrument(s), ie whether this Directive shall stay a Directive or shall be merged into a Regulation is yet to be decided. This paper will look at these developments beyond the context of the pandemic and also consider the typical regulatory circumstances. The paper concludes that compared to a Regulation, the Directive remains the preferable legal instrument to provide the framework for nationally/decentralised authorised medicinal products. Both the Directive and the Regulation in their coexistence should continue being the main pillars of the basic EU pharmaceutical legislation.

Christine Mellein is Head of European and Public Law & Governmental Affairs at Heel. For Correspondence: Prof Dr Dres hc Jürgen Schwarze is Professor Emeritus of German and Foreign Public Law, European Law and International Law at the University of Freiburg. For Correspondence:


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